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VIVUS Reports Second Quarter And First Six Months 2013 Financial Results

MOUNTAIN VIEW, Calif., Aug. 6, 2013 (GLOBE NEWSWIRE) -- VIVUS,Inc. (Nasdaq:VVUS) ("VIVUS"), which sells the obesity drug Qsymia ® (phentermine and topiramate extended-release) capsules CIV in the United States, today provided a business update and reported its financial results for the second quarter and six months ended June 30, 2013.

Recent Highlights
  • On July 22, 2013, we announced that our Board of Directors had appointed Michael Astrue to serve as its non-executive chairman of the Board of Directors and Anthony (Tony) Zook to serve as our chief executive officer. Mr. Zook was also appointed to our Board of Directors on July 25, 2013. Mr. Astrue formerly served as chief executive officer of Transkaryotic Therapies, chairman of the Massachusetts Biotechnology Council, and Commissioner of Social Security. Mr. Zook formerly served as executive vice president for Global Commercial Operations for AstraZeneca and president of MedImmune. "It is a pleasure to join VIVUS as CEO and I look forward to working with the VIVUS team, including the Board of Directors," stated Tony Zook, chief executive officer of VIVUS. "We intend to move quickly on four main goals: 1) expand use of Qsymia through targeted patient and physician education; 2) find the right partner for Qsymia to expand PCP reach; 3) create a pathway for centralized approval in Europe; and 4) eliminate expenses that are not essential to expanding use of Qsymia. We are already making progress on these four goals."  
  • On July 18, 2013, we entered into a settlement agreement with First Manhattan Co., or the Settlement Agreement, terminating the pending proxy contest with respect to the election of our Board of Directors at our 2013 annual meeting of stockholders, or the Annual Meeting. The Settlement Agreement provides that the Annual Meeting be adjourned to August 14, 2013.  
  • On July 1, 2013, we announced initial availability of Qsymia through approximately 8,000 Walgreens, Costco and Duane Reade retail pharmacies nationwide. As of today, the number of retail pharmacies through which Qsymia is available is approaching 10,000 nationwide. We intend to continue certifying and adding to the Qsymia retail pharmacy network, including well-known national and regional chains as well as independent pharmacies, in the coming weeks and months.  
  • On June 26, 2013, the European Commission, or EC, adopted the implementing decision granting marketing authorization for SPEDRA™ (the approved trade name for avanafil in the European Union, or EU) for the treatment of erectile dysfunction (ED) in the EU.  
  • On July 5, 2013, we entered into a License and Commercialization Agreement, or the SPEDRA Agreement, and a Commercial Supply Agreement with Menarini to commercialize and promote SPEDRA for the treatment of ED in over 40 European countries, plus Australia and New Zealand. Under the SPEDRA Agreement, we will receive an upfront payment and various approval and sales milestones plus royalties on SPEDRA sales. Within the first year, we expect to receive approximately €39 million, including upfront payments totaling €16 million. Menarini will also reimburse us for payments made to cover various obligations to MTPC during the term of the SPEDRA Agreement. We are eligible to receive up to €79 million in milestones and other payments over the life of the SPEDRA Agreement in addition to royalties.  
  • On June 19, 2013, we announced study results showing avanafil is effective for sexual activity within 15 minutes in men with ED. In the study, avanafil patients achieved statistically significant improvement over placebo, in the mean proportion of attempts that resulted in erections sufficient for successful intercourse, as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose after being taken. We intend to file an amendment to the current STENDRA and SPEDRA labels to include these results.  
  • On May 21, 2013, we closed an offering of $220.0 million in 4.5% Convertible Senior Notes due May 1, 2020, or the Convertible Notes. In addition, on May 29, 2013, the Initial Purchasers exercised in full their option to purchase an additional $30.0 million aggregate principal amount of the Convertible Notes. Total net proceeds from the Convertible Notes were approximately $241.8 million. The Convertible Notes are senior unsecured obligations of the Company and bear interest at a fixed rate of 4.50% per annum, payable semiannually in arrears on May 1 and November 1 of each year, beginning on November 1, 2013, unless earlier purchased or converted.

Second Quarter Financial Results

In the second quarter of 2013, net product revenue from sales of Qsymia was $5.5 million. For the quarter ended June 30, 2013, we reported a net loss of $55.5 million, or $0.55 net loss per share, as compared to a net loss of $24.0 million, or $0.24 net loss per share during the second quarter of 2012. The increased net loss in the second quarter of 2013, as compared to the second quarter of 2012, is primarily attributable to increased selling, general and administrative expenses related to commercialization activities for Qsymia. Included in the net loss for the quarter ended June 30, 2013 were $2.8 million related to the proxy contest and a total charge of $4.4 million for Qsymia inventories on hand in excess of demand, plus a purchase commitment fee due to the manufacturer of Qsymia.

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